אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - palonosetron hydrochloride, quantity: 280.8 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: hydrochloric acid; disodium edetate; sodium citrate dihydrate; sodium hydroxide; water for injections; mannitol; citric acid monohydrate - indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - palonosetron hydrochloride, quantity: 280.8 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: citric acid monohydrate; mannitol; disodium edetate; sodium citrate dihydrate; hydrochloric acid; water for injections; sodium hydroxide - indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sciegen pharmaceuticals, inc. - metaxalone (unii: 1nma9j598y) (metaxalone - unii:1nma9j598y) - metaxalone 800 mg - metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. metaxalone does not directly relax tense skeletal muscles in man. known hypersensitivity to any components of this product. known tendency to drug induced, hemolytic, or other anemias. significantly impaired renal or hepatic function.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

bluepoint laboratories - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat course of highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride is contraindicated in patients known to have hypersensitivity to palonosetron [see  warning and precautions   error! hyperlink reference not valid. )] risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron hcl at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral dosed up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for palonosetron hydrochloride and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. chemotherapy-induced nausea and vomiting safety and effectiveness of palonosetron hydrochloride injection have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hec. use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see clinical studies ( 14.2) ]. while this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [see adverse reactions ( 6.1) ]. safety and effectiveness of palonosetron hydrochloride injection in neonates (less than 1 month of age) have not been established. postoperative nausea and vomiting studies safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. two pediatric trials were performed. pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). a total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. no dose responses were observed. pediatric study 2, a multicenter, double-blind double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron hcl (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. a total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. the primary efficacy endpoint, complete response (cr: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. given the pre-specified non-inferiority margin of -10%, the stratum adjusted mantel-haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (cr), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. adverse reactions to palonosetron were similar to those reported in adults. of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron hcl, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. of the 1520 adult patients in clinical studies of intravenously administered palonosetron hcl, 73 (5%) were at least 65 years old [ see clinical studies ( 14.1, 14.3]. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out. population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see clinical pharmacology ( 12.3)]. no dose adjustment is required for geriatric patients.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

apotex corp. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1)] . risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron hcl at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for palonosetron hydrochloride injection and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. chemotherapy-induced nausea and vomiting safety and effectiveness of palonosetron hydrochloride injection have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hec. use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron hydrochloride injection 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see clinical studies (14.2)] . while this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [ see adverse reactions (6.1)] . safety and effectiveness of palonosetron hydrochloride injection in neonates (less than 1 month of age) have not been established. postoperative nausea and vomiting studies safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. two pediatric trials were performed. pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). a total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. no dose response was observed. pediatric study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron hcl (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. a total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. the primary efficacy endpoint, complete response (cr: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. given the pre-specified non-inferiority margin of -10%, the stratum adjusted mantel-haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (cr), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. adverse reactions to palonosetron were similar to those reported in adults. of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron hcl, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. of the 1520 adult patients in clinical studies of intravenously administered palonosetron hcl, 73 (5%) were at least 65 years old [see clinical studies (14.1, 14.3)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out. population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see clinical pharmacology (12.3)] . no dose adjustment is required for geriatric patients.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

northstar rx llc - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1)] . risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron hcl at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for palonosetron hydrochloride and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. chemotherapy-induced nausea and vomiting safety and effectiveness of palonosetron hydrochloride injection have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hec.  use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron hydrochloride injection 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see clinical studies (14.2)] . while this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [ see adverse reactions (6.1)] . safety and effectiveness of palonosetron hydrochloride in neonates (less than 1 month of age) have not been established. postoperative nausea and vomiting studies safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. two pediatric trials were performed. pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). a total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. no dose response was observed. pediatric study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron hcl (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. a total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. the primary efficacy endpoint, complete response (cr: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. given the pre-specified non-inferiority margin of -10%, the stratum adjusted mantel-haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (cr), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. adverse reactions to palonosetron were similar to those reported in adults. of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron hcl, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. of the 1520 adult patients in clinical studies of intravenously administered palonosetron hcl, 73 (5%) were at least 65 years old [see clinical studies (14.1, 14.3)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out.  population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see clinical pharmacology (12.3)] . no dose adjustment is required for geriatric patients.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

baxter healthcare corporation - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1) ]. risk summary there are no available data on palonosetron hydrochloride use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hydrochloride during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron hydrochloride at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for palonosetron hydrochloride and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. chemotherapy-induced nausea and vomiting safety and effectiveness of palonosetron hydrochloride injection have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hec. use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron hydrochloride injection 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see clinical studies (14.2) ]. while this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [see adverse reactions (6.1) ]. safety and effectiveness of palonosetron hydrochloride in neonates (less than 1 month of age) have not been established. postoperative nausea and vomiting studies safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. two pediatric trials were performed. pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). a total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. no dose response was observed. pediatric study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron hydrochloride (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. a total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. the primary efficacy endpoint, complete response (cr: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. given the pre-specified non-inferiority margin of -10%, the stratum adjusted mantel-haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (cr), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. adverse reactions to palonosetron were similar to those reported in adults. of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron hydrochloride, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. of the 1520 adult patients in clinical studies of intravenously administered palonosetron hydrochloride, 73 (5%) were at least 65 years old [see clinical studies (14.1, 14.3) ]. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out. population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see clinical pharmacology (12.3) ]. no dose adjustment is required for geriatric patients.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

athenex pharmaceutical division, llc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1)] . risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron hcl at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for palonosetron hydrochloride injection and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. chemotherapy-induced nausea and vomiting safety and effectiveness of palonosetron hydrochloride injection have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hec. use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron hydrochloride injection 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see clinical studies (14.2)] . while this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [see adverse reactions (6.1)] . safety and effectiveness of palonosetron hydrochloride injection in neonates (less than 1 month of age) have not been established. postoperative nausea and vomiting studies safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. two pediatric trials were performed. pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). a total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. no dose response was observed. pediatric study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron hcl (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. a total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. the primary efficacy endpoint, complete response (cr: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. given the pre-specified non-inferiority margin of -10%, the stratum adjusted mantel-haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (cr), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. adverse reactions to palonosetron were similar to those reported in adults. of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron hcl, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. of the 1520 adult patients in clinical studies of intravenously administered palonosetron hcl, 73 (5%) were at least 65 years old [see clinical studies (14.1, 14.3)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out. population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see clinical pharmacology (12.3)] . no dose adjustment is required for geriatric patients.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - palonosetron hydrochloride, quantity: 280 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium citrate dihydrate; sodium hydroxide; mannitol; disodium edetate; citric acid monohydrate - palonosetron baxter is indicated for:,? prevention of nausea and vomiting induced by cytotoxic chemotherapy,? prevention of postoperative nausea and vomiting (ponv) for up to 24 hours following surgery.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - palonosetron hydrochloride, quantity: 56 microgram/ml - injection, solution - excipient ingredients: mannitol; citric acid monohydrate; water for injections; sodium citrate dihydrate - palonosetron is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.